Tag: Consent Decree

AMSTERDAM – Philips expects to record a EUR 1.3 billion non-cash charge in the third quarter for the impairment of goodwill of its Sleep & Respiratory Care business due to revisions to the financial forecast of the business.  The company says the drivers for the revised forecast include current assumptions regarding the estimated impact of the proposed consent decree and changes to the pre-tax discount rate.  Philips announced in July that it had begun discussions with the U.S....

AMSTERDAM – Philips has established a “recovery trajectory” for its sleep and respiratory care business, but discussions with the U.S. Department of Justice on a proposed consent decree to resolve identified issues could impact the company’s plans. The company’s trajectory includes an estimated EUR 600 million in sales of Respironics sleep systems by 2025, up from an expected EUR 200 million in 2022 and more in line with the EUR 700 million in 2019, pre-recall.  “This...

ELYRIA, Ohio - Invacare will reduce its workforce by about 110 employees to generate $8.5 million in pre-tax savings, the company announced Dec. 7.The move, which affects employees in North America, is part of a multi-year strategic plan to transforms Invacare into a more clinically focused company, says Matthew Monaghan, chairman, president and CEO.“This reduction in force, while difficult, is an essential part of the second phase of our transformation toward becoming a more sustainably profitable,...

ELYRIA, Ohio - After a consent decree with the U.S. Food and Drug Administration forced Invacare to reduce its workforce a number of times in the past few years, the company is ready to hire again.Invacare is hosting a job fair today at its corporate headquarters, with an eye toward hiring workers skilled in computer numerical control, welding, assembly, sewing and machine operation, according to The Chronicle Telegram.Invacare's Lara Mahoney told the local newspaper that the company is looking to...

ELYRIA, Ohio - Invacare reported $233.5 million in net sales for the second quarter of this year compared to $275 million for the same period last year, a 15.1% decrease.For the North America/HME business segment, it reported $77.7 million in net sales compared to $110.7 million, an 86.4% decrease.“As indicated previously, we expected net sales to continue to decline through the first half of 2017 before stabilizing sequentially later in the year,” said Matthew Monaghan, chairman, president...

ELYRIA, Ohio �- Invacare looks forward to re-introducing providers to a “different company” now that it has the green light to resume full operations at its corporate headquarters and Taylor Street facilities. The U.S. Food and Drug Administration notified Invacare in a letter dated July 24 that the company has satisfied requirements under a consent decree that has limited its ability to make and sell products from the facilities for nearly five years, since December 2012. “When...

ELYRIA, Ohio - Invacare has the green light to make and sell products again from its Taylor Street manufacturing facility and corporate headquarters here, the company announced July 25. A consent decree with the U.S. Food and Drug Administration has limited Invacare's ability to make and sell products from the facilities for nearly five years, since December 2012. “Invacare can design, manufacture, process, pack, repack, label, hold, distribute, import into or export from the United...

ELYRIA, Ohio - Now that Invacare has made significant progress toward lifting a consent decree with the U.S. Food and Drug Administration, it's paving the way to launch a robust pipeline of new products later this year, company officials told analysts during an earnings call May 9. In the first half of 2017, Invacare expects continued lower net sales—offset by favorable sales mix and increased gross margin as a percent of net sales—but by the end of the year, it expects a “sustainable...

ELYRIA, Ohio - Invacare has completed the final milestones required to lift a consent decree with the U.S. Food and Drug Administration, paving the way for a re-inspection, the company announced April 27.“The re-inspection is an important step before the company may resume full operations at the impacted facilities,” Invacare stated in a press release.The decree has limited Invacare's ability to manufacture and sell certain products from its corporate headquarters and Taylor Street facilities...

ELYRIA, Ohio - The U.S. Food and Drug Administration will now pick back up on a third and final certification report submitted by Invacare's third-party auditor. The FDA on April 13 notified Invacare that it has accepted an updated second certification report submitted by the company's third-party auditor, allowing it to resume design activities at its corporate headquarters and Taylor Street manufacturing facilities in Elyria. “It's good to have this milestone, but there's...